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niacin laropiprant simvastatin

Phase 3

Primary Hypercholesterolemia | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Apr 7, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment1,400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00269217Lipid Efficacy Study (0524B-022)(COMPLETED)PHASE3 COMPLETED 1,400 — — Jan 1, 2006Jan 1, 2007Apr 7, 2017 - —
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Study Endpoints
Primary Endpoints
Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
Secondary Endpoints
Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin.
Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK0524A.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
niacin (+) laropiprant (+) simvastatinDRUGDuration of Treatment 12 Weeks
Comparator: niacin (+) laropiprantDRUGDuration of Treatment 12 Weeks
Comparator: simvastatinDRUGDuration of Treatment 12 Weeks
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia * LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides \</= 350 mg/dL. Exclusion Criteria: * A condition which, in the opinion of the investig...

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